Uses
What is Trelegy Ellipta used for?
Trelegy Ellipta (fluticasone/umeclidinium/vilanterol) is commonly used as a controller inhaler for the following conditions.
- Asthma
- Chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema
Trelegy Ellipta may also be used for other conditions as determined by your healthcare provider.
How does Trelegy Ellipta work (mechanism of action)?
People with asthma or COPD have chronic and ongoing airflow problems in the lungs. Trelegy Ellipta contains three medicines. One medicine, fluticasone, reduces swelling (inflammation) in the lungs. The other two medicines, umeclidinium and vilanterol, relax the muscles around the airways. This can help to make it easier to breathe.
Learn more about How Trelegy Ellipta Works for Asthma.
Learn more about How Trelegy Ellipta Works for COPD.
How is Trelegy Ellipta supplied (dosage forms)?
Trelegy Ellipta is available in the following dosage forms that are inhaled by mouth.
- 100 mcg/62.5 mcg/25 mcg inhalation powder (Ellipta inhaler)
- 200 mcg/62.5 mcg/25 mcg inhalation powder (Ellipta inhaler)
How should I store Trelegy Ellipta?
Trelegy Ellipta should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place away from direct heat or sunlight.
Keep the inhaler inside of its unopened foil tray until you are ready to use it. Once the foil tray has been opened, Trelegy Ellipta is only good for 6 weeks. If the inhaler is not empty after 6 weeks, it should be thrown out and replaced.
Side Effects
What are the most common side effects of Trelegy Ellipta?
The most common side effects of Trelegy Ellipta are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Lung infections, such as bronchitis or pneumonia
- Headache
- Back pain
- Joint pain
- Flu
- Symptoms of a urinary tract infection (UTI), such as painful or frequent peeing
- Oral thrush (see below)
There may be other side effects of Trelegy Ellipta that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Trelegy Ellipta?
While less common, the most serious side effects of Trelegy Ellipta are described below, along with what to do if they happen.
Reduced Adrenal Function. Long-term use of Trelegy Ellipta can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. This is especially a concern if you have been taking a corticosteroid by mouth, such as prednisone or methylprednisolone, and you stop it and switch to Trelegy Ellipta. Adrenal insufficiency can also get worse if your body is under stress because of fever, surgery, or trauma. Contact your healthcare provider right away if you experience the following symptoms of adrenal suppression. Do not stop using your Trelegy Ellipta.
- Low blood pressure
- Nausea or vomiting
- Weakness, tiredness, or lack of energy
Sudden Breathing Problems. Trelegy Ellipta may cause the muscles around the airways to tighten (bronchospasm) instead of relaxing, which can be serious. Stop using Trelegy Ellipta and contact your healthcare provider right away if your ability to breathe worsens right after using the medicine.
Glaucoma or Cataracts. Using Trelegy Ellipta for a long time may increase pressure inside the eye and cause or worsen narrow-angle glaucoma, which can lead to blindness. It may also increase the risk of cataracts. Tell your healthcare provider right away if you have any of the following symptoms of glaucoma or cataracts.
- Loss of vision or vision changes
- Eye pain or redness
- Severe headache or vomiting
- Seeing bright, colorful circles around lights (vision halos)
Inability to Empty Bladder (Urinary Retention). Trelegy Ellipta might make it harder to empty your bladder, especially if you already have a blockage or trouble peeing. Stop using Trelegy Ellipta and call your healthcare provider right away if you have a hard time peeing or have a weak stream, if peeing is painful, or you are peeing frequently.
Heart Effects. Trelegy Ellipta may increase your risk of certain effects on the heart, such as raising your heart rate, blood pressure, or causing an abnormal heart rhythm (arrhythmia). If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Also call your healthcare provider or get medical attention right away if you have chest pain, a fast or irregular heartbeat, or if you feel your heartbeat more than usual.
Increased Blood Sugar. Trelegy Ellipta may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels.
Infection. Trelegy Ellipta can increase the risk of infections, including serious infections. Call your healthcare provider if you have any of the following symptoms.
- Bumpy red rash
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
Low Potassium Level (Hypokalemia). Trelegy Ellipta can cause a low potassium level, which can be serious. Your healthcare provider will check your potassium levels, especially if you take certain other medicines. Call your healthcare provider if you have any of the following symptoms of a low potassium level.
- Weakness
- Unusual tiredness
- Muscle cramps or twitching
- Constipation
Nervous System Effects. Trelegy Ellipta may cause nervous system effects, including tremor or nervousness. Contact your healthcare provider right away if you develop these symptoms.
Oral Thrush. Trelegy Ellipta can sometimes cause the mouth and throat to become infected with a type of yeast, a condition known as oral thrush or oral candidiasis. Contact your healthcare provider if you notice any of the following symptoms of oral thrush.
- Cracking in the corners of the mouth
- Loss of taste
- Red or white patches in the mouth or throat
- Raised white spots in the mouth or throat
Pneumonia. Pneumonia is an infection of the lungs that can make it hard to breathe. Some people with COPD who use Trelegy Ellipta have developed pneumonia. Contact your healthcare provider right away if you have any of the following symptoms of pneumonia.
- Trouble breathing
- Increased mucus or change in mucus color
- Worsening cough
- Fever or chills
Severe Allergic Reactions. Trelegy Ellipta can cause allergic reactions, which can be serious. Stop using Trelegy Ellipta and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Slow Growth. In people who are still growing, such as children and adolescents, Trelegy Ellipta may slow down growth. If you use Trelegy Ellipta while you are still growing, your healthcare provider will monitor your growth rate.
Weak Bones. Using Trelegy Ellipta for a long time may cause the bones to become weaker, leading to reduced bone density (osteopenia). It may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. Your healthcare provider may monitor your bone density while you are taking Trelegy Ellipta.
Warnings & Precautions
Who should not use Trelegy Ellipta?
Allergies to Ingredients. People who are allergic to any of the following should not use Trelegy Ellipta.
- Fluticasone
- Lactose
- Milk proteins
- Trelegy Ellipta
- Umeclidinium
- Vilanterol
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Trelegy Ellipta.
Sudden COPD or Asthma Symptoms. People who are currently experiencing a sudden worsening of symptoms, such as from an asthma attack or a COPD flare-up, should not use Trelegy Ellipta to treat these symptoms. Trelegy Ellipta should be used daily to prevent and manage symptoms. Do not use it as a rescue inhaler.
What should I know about Trelegy Ellipta before using it?
Do not use Trelegy Ellipta unless it has been prescribed to you by a healthcare provider. Use it as prescribed. Using Trelegy Ellipta more often than prescribed may increase the risk of serious side effects.
Do not share Trelegy Ellipta with other people, even if they have the same condition as you. It may harm them.
Keep Trelegy Ellipta out of the reach of children.
Trelegy Ellipta is a medicine used daily to prevent symptoms. Do not use it when a quick response to breathing problems is needed. Other inhaled medicines, sometimes called rescue inhalers, should be used to treat sudden symptoms. Get medical help right away if your breathing does not get better after using a rescue inhaler.
After using Trelegy Ellipta, rinse your mouth out with water and spit the water out. This helps lower your chance of getting a fungal infection in your mouth or throat, also called oral thrush.
What should I tell my healthcare provider before using Trelegy Ellipta?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Trelegy Ellipta is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Bladder problems
- An infection, a history of immune problems or severe infections, or if you have been exposed to chickenpox or measles
- Diabetes
- Eye problems, such as glaucoma or cataracts
- Heart problems, including arrhythmias
- High blood pressure
- History of bone conditions, such as osteomalacia, osteopenia, or osteoporosis, or if you are at risk for weak bones, such as if you use tobacco or are inactive for a long period of time
- Liver problems
- Prostate problems
- Seizures
- Thyroid problems
Other Medicines and Supplements. Trelegy Ellipta may interact with other medicines and supplements. Before using Trelegy Ellipta, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Trelegy Ellipta could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Trelegy Ellipta passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Trelegy Ellipta?
For more information about Trelegy Ellipta, you can visit the manufacturer’s website at www.trelegy.com or call them at 888-825-5249.
Interactions
Does Trelegy Ellipta interact with foods or drinks?
There are no known interactions between Trelegy Ellipta and foods or drinks.
It is unknown if drinking alcohol will affect Trelegy Ellipta.
Does Trelegy Ellipta interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Trelegy Ellipta.
- A beta-blocker, such as metoprolol (Lopressor), atenolol (Tenormin), or propranolol (Inderal LA), which is a medicine that may be used for certain heart conditions or to reduce blood pressure
- A diuretic, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure
- A long-acting beta-2 agonist (LABA), such as salmeterol (Serevent), formoterol (Perforomist), arformoterol (Brovana), or olodaterol (Striverdi), which is an inhaled medicine used to help control asthma or COPD
- A medicine for HIV or AIDS
- A monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease
- A tricyclic antidepressant within the past 2 weeks, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
- Medicines within the past 2 weeks that can cause QT prolongation, which is a dangerous heart rhythm problem
- An anticholinergic medicine, which includes atropine, antihistamines, and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems. Some anticholinergic medicines are inhaled, such as tiotropium (Spiriva), ipratropium (Atrovent), and aclidinium (Tudorza)
- Clarithromycin, an antibiotic
- An antifungal medicine, such as ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend) which are medicines used for fungal infections
Some other medicines may alter the blood levels of Trelegy Ellipta. Tell your healthcare provider about all medicines that you take or have recently taken.
Overdose/Missed Dose
What should I do if I accidentally use too much Trelegy Ellipta?
If you or someone else has used too much Trelegy Ellipta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Trelegy Ellipta?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
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